Gujarat Government will be soon initiating steps to set up India’s first dedicated medical device testing lab in partnership with the Union Health Ministry and with technical support of Healthcare Technology Division of National Health Systems Resource Centre (NHSRC), a technical support institution under the Union health ministry.
These testing labs will allow manufacturers to overcome deficiencies in their products and enhance product value in the market which has been a hitherto neglected aspect. It will also ensure safety and efficacy of medical devices marketed in the country.
NHSRC, which had surveyed 16 testing labs in the country and nine medical device testing labs across the globe had submitted a report to the government specifying the need and also the modalities required for setting up such a dedicated medical device testing lab based on the standards existing globally.
Recommended and promoted by the Union Commerce Ministry to help Indian manufacturers gain self-reliance in medical device testing, Rs 15 crore has already been earmarked for the same, according to an official associated with the development.
Though the government plans to set up two medical device testing labs-one at Vadodara in Gujarat and another at Noida , medical device testing lab in Gujarat would be the first and the only dedicated bio-materials and implants testing lab in the country. The lab at Noida will be set up primarily to test electrical and electronic medical devices in the country.
Due to lack of a reliable and advanced medical device testing facility in the country, products are usually sent to foreign countries for testing. Moreover, a few testing labs in the country which offer testing have been found to be redundant and obsolete.
Work for the lab at Vadodara will start as and when funds are released by the Central Government. The testing lab, which will be housed at Gujarat Food and Drug Control Administration (FDCA) office located in the middle of a thriving industrial belt, is likely to materialise in the coming two months.
Boon for domestic manufacturers
The planned medical device testing labs would be a boon for the Indian manufacturers to be compliant towards patient safety as the country today lags in registering and thereby reporting adverse events due to faulty medical devices at the point of care.
In order to comply with all safety requirements, sets of universal standards and norms have been prescribed, compliance to which ensures delivery of right technology in the right way. A means to verify the devices against this desired compliance is testing.
Thus, product testing brings into existence the first level of assessment of appropriateness and safety of a device. This would complement the government's ‘Make in India’ drive pushing industrial growth and encouraging medical devices sector in the country.
Industry- academia collaborations
NIPER Ahmedabad is also planning to collaborate with international organisations and Gujarat Food and Drug Control Administration (FDCA) following two MoUs with Indian medical devices manufacturers to initiate setting up of the government mandated National Centre for Medical Devices (NCMD).
This would complement the upcoming medical device testing lab at Vadodara by the end of this year. The DoP, for the last one year, has actively engaged the NIPERs across the country and the pharma industry to build partnership in areas of education, research and development.
NIPER Ahmedabad has signed two MoUs with Johnson & Johnson and Sahajanand Laser Technologies to develop an ecosystem for development of medical devices sector in the country. This collaboration will help customise NIPER curriculum for development of skilled manpower in the sector.
As per official sources, a total of 17 MoUs were signed between seven NIPERs of the country and pharma industry for academia industry linkages recently. Academia-industry linkage is a significant development as one of the critical factors in building an innovative ecosystem for medical devices industry.
DoP has identified academia-industry linkage as a basic requirement for translating research into development (commercialisation) and innovation; and also to fix accountability among the educational institutions. Further in India, the research and development in pharmaceuticals sector is spread across a number of ministries and departments viz., department of biotechnology, department of science and technology, department of scientific and industrial research, health systems research, Indian Council of Medical (ICMR) and department of pharmaceuticals.
High quality and skilled manpower is one of the critical requirements in the pharma sector today. This has gained further impetus as the Government of India is planning to expand NIPERs across the country to nurture manpower and hence boost domestic manufacturing of medical devices in the country. More than 70 per cent of medical devices are imported as of today which has impacted the development of the domestic industry.
NIPERs are institutions of national importance set up under NIPER Act, 1998 on the lines of IITs. Presently, there are seven NIPERs functional at Mohali, Ahmedabad, Guwahati, Hajipur, Hyderabad, Kolkata and Raebareli. One more NIPER is being set up at Madurai . During 2015-16, three new NIPERs were announced for Chattisgarh, Maharashtra and Rajasthan.
Industry-oriented skill training
In order to develop analytical and technical knowledge of pharmacy students in quality control of biologicals, the National Institute of Biologicals (NIB) functioning under the Union health ministry organised a two-week long training session for post graduate students of pharmacy from NIPERs from across the country respectively in NOIDA, Guwahati, Punjab and Kolkata.
The training session which was also in line with NIB mandate as laid down in Memorandum of Association will also help create awareness about global scenario of biologicals testing and laboratory quality management system as per ISO: 17025.
Themed as National Skill Development and Hands-on-Training on Quality Control of Biologicals, the programme designed exclusively for pharmacy post graduate students of NIPER offered hands-on training in areas of bio-therapeutics, vaccines, diagnostics, blood products and blood group serology in techniques like HPLC, electrophoresis, ELISA, bacterial endotoxin testing, cell culture aseptic handling, sub-culturing and maintenance, cell line based potency assays, animal handling and use of laboratory animals in QC testing of biologicals.
As a part of the programme, training is also provided on Haemovigilance Programme of India (HvPI), Haemo-vigil software and planning and carrying out a National Drug Survey for Spurious and NSQ Drugs in the Country.
This initiative which is in accordance with NIB mandate 3.1.4 as laid down in Memorandum of Association will facilitate in building up of a “National Talent Pool of Skilled and Trained Manpower” for the indigenous manufacturing, domestic consumption and export of biologicals.
This will help bridge the gap in quality control of biologicals in government and private sector as there is an acute shortage of skilled and hands-on trained manpower in the field of biologicals.
Make in India campaign
This training programme further has been initiated keeping in mind the Prime minister Narendra Modi's - Pradhan Mantri Kaushal Vikas Yojana (PMKVY) which emphasizes on “Skilling is building a better India. If we have to move India towards development then skill development should be our mission”.
Hands-on-training training is given in quality control of biologicals in NABL accredited and CDL notified laboratories of NIB. The training sessions also include lectures and presentations from distinguished and eminent speakers from the institute and academia.